Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT01622504
Status:
UNKNOWN
Last Update Posted:
2012-06-20
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naloxone Nasal Spray Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083682', 'term': 'Opiate Overdose'}, {'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm', 'description': 'Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2)'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': '14 days', 'description': 'Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose'}, {'measure': 'Physical Examination', 'timeFrame': '14 days', 'description': 'Complete physical examination at screening and final follow-up and specific nasal examination post-dose'}, {'measure': 'Vital signs', 'timeFrame': '14 days', 'description': 'Vital signs at screening, final follow-up and pre- and post-dose'}, {'measure': 'ECGs', 'timeFrame': '14 days', 'description': 'ECGs at screening and final follow-up'}, {'measure': 'Safety Laboratory Tests', 'timeFrame': '14 days', 'description': 'Haematology, biochemistry and urinalysis at screening and final follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intranasal', 'nasal spray', 'opioid', 'overdose'], 'conditions': ['Opioid Overdose']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).', 'detailedDescription': 'Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* 18-60 50 years of age\n* Provide written informed consent prior to completing any study specific procedure.\n* Body Mass Index (BMI) range 18.5-30 kg/m2\n* Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG\n* Using reliable contraception\n\nExclusion Criteria:\n\n* Intranasal problems\n* Taking prescribed or over the counter medications\n* Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.'}, 'identificationModule': {'nctId': 'NCT01622504', 'briefTitle': 'Naloxone Nasal Spray Pharmacokinetic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mitovie Pharma Ltd'}, 'officialTitle': 'A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'MVP005-CLN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product Dose 1', 'interventionNames': ['Drug: MVP005']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product Dose 2', 'interventionNames': ['Drug: MVP005']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Product', 'interventionNames': ['Drug: Naloxone hydrochloride solution for injection with mucosal atomization device']}], 'interventions': [{'name': 'MVP005', 'type': 'DRUG', 'description': '2 mg single dose administered intranasally', 'armGroupLabels': ['Test Product Dose 1']}, {'name': 'MVP005', 'type': 'DRUG', 'description': '4 mg single dose administered intranasally', 'armGroupLabels': ['Test Product Dose 2']}, {'name': 'Naloxone hydrochloride solution for injection with mucosal atomization device', 'type': 'DRUG', 'description': '2 mg single dose administered intranasally', 'armGroupLabels': ['Comparator Product']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'contacts': [{'name': 'Rana Hassan, MSc', 'role': 'CONTACT', 'email': 'r.hassan@iprc.com.jo', 'phone': '+96265627651'}, {'name': 'Halah Zqqout, BSc', 'role': 'CONTACT', 'email': 'h.zqqout@iprc.com.jo', 'phone': '+96265627651'}, {'name': 'Abdullah Hiyari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Pharmaceutical Research Center (IPRC)', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Rana Hassan, MSc', 'role': 'CONTACT', 'email': 'r.hassan@iprc.com.jo', 'phone': '+96265627651'}, {'name': 'Halah Zqqout, BSc', 'role': 'CONTACT', 'email': 'h.zqqout@iprc.com.jo', 'phone': '+96265627651'}], 'overallOfficials': [{'name': 'Abdullah Hiyari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IPRC, Jordan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mitovie Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}